[Code of Federal Regulations] [Title 42, Volume 3] [Revised as of October 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 42CFR486.306] [Page 626-628] TITLE 42--PUBLIC HEALTH CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 486_CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED BY SUPPLIERS--Table of Contents Subpart G_Conditions for Coverage: Organ Procurement Organizations Sec. 486.306 Qualifications for designation as an OPO. To be designated as the OPO for a service area, an organization must, at the time of application and throughout the period of its designation, meet the following requirements: (a) Be a nonprofit entity that is exempt from Federal income taxation under section 501 of the Internal Revenue Code of 1986. (b) Have accounting and other fiscal procedures necessary to assure the fiscal stability of the organization, including procedures to obtain payment for kidneys and non-renal organs provided to transplant centers. [[Page 627]] (c) Have an agreement with the Secretary to be reimbursed under Medicare for the procurement of covered organs. (d) Document that it has a defined service area that meets the requirements of Sec. 486.307. (e) Have a director and such other staff, including an organ donation coordinator and an organ procurement specialist, necessary to obtain organs effectively from donors in its service area. (f) Have a board of directors or an advisory board that has the authority to recommend policies relating to the donation, procurement, and distribution of organs. While an OPO may have more than one board, the members specified in paragraphs (f)(1) through (f)(5) of this section must be members of a single board. The board of directors or advisory board must be composed of the following: (1) Members who represent hospital administrators, tissue banks, voluntary health associations in its service area and either intensive care or emergency room personnel. (2) Members who represent the public residing in that area. (3) A physician with knowledge, experience, or skill in the field of human histocompatibility, or an individual with a doctorate degree in a biological science and with knowledge, experience, or skills in the field of human histocompatibility. (4) A neurosurgeon or another physician with knowledge or skills in the field of neurology. (5) A transplant surgeon from each transplant center in its service area with which the OPO has arrangements to coordinate its activities. (g) To identify potential organ donors, have documented evidence that--(1) It has a working relationship with at least 75 percent of the hospitals that participate in the Medicare and Medicaid programs in its service area and that have an operating room and the equipment and personnel for retrieving organs; and (2) It conducts systematic efforts intended to acquire all usable organs from potential donors. (h) Arrange for the appropriate tissue typing of donated organs. (i) Have a system to equitably allocate donated organs among transplant patients that is consistent with-- (1) ``Guidelines for Preventing Transmission of Human Immunodeficiency Virus Through Transplantation of Human Tissue and Organs'' issued by the Centers for Disease Control and Prevention (CDC) that are appended to this subpart; and (2) Rules of the Organ Procurement and Transplantation Network (OPTN), see Sec. 486.308. (j) Provide or arrange for the transportation of donated organs to transplant centers. (k) Have arrangements to coordinate its activities with transplant centers in the area. (l) Have arrangements to cooperate with tissue banks for the retrieval, processing, preservation, storage and distribution of tissues as may be appropriate to assure that all usable tissues are obtained from potential donors. (m) Maintain and make available upon request of the Secretary, the Comptroller General, or their designees data that relate to the performance standards. (n) Maintain data in a format that can be readily used by a successor OPO and agree to turn over to the Secretary copies of all records and data necessary to assure uninterrupted service by a successor OPO newly designated by CMS. (o) Have a procedure for ensuring the confidentiality of patient records. Information from or copies of records may be released only to authorized individuals and the OPO must ensure that unauthorized individuals cannot gain access to or alter patient records. Original medical records may be released by the OPO only in accordance with Federal or State laws, court orders, or subpoenas. (p) Conduct and participate in professional education concerning organ procurement. (q) Ensure that appropriate donor screening and infection tests, consistent with OPTN standards and the CDC guidelines that are appended to this subpart, are performed by a laboratory that is certified in the appropriate specialty or subspecialty of service in accordance with part 493 of this [[Page 628]] chapter, including tests to prevent the acquisition of organs that are infected with the etiologic agent for acquired immune deficiency syndrome. (r) Assist hospitals in establishing and implementing protocols for making routine inquiries about organ donations by potential donors. (s) Ensure that donors are tested for human immunodeficiency viral markers consistent with OPTN rules and the CDC guidelines appended to this subpart for solid organ donation. (t) Submit accurate data to CMS within 15 days following the end of a calendar year (unless otherwise notified) giving information on the following: (1) Population of designated service area based on the most recent U.S. Bureau of the Census data. (2) Number of actual donors. (3) Number of kidneys procured. (4) Number of kidneys transplanted. (5) Number of extrarenal organs by type procured. (6) Number of extrarenal organs by type transplanted. [53 FR 6550, March 1, 1988; 53 FR 9172, March 21, 1988; 53 FR 18987, May 26, 1988; 57 FR 7137, Feb. 28, 1992; 59 FR 46515, Sept. 8, 1994. Redesignated and amended at 60 FR 50447, 50448, Sept. 29, 1995; 61 FR 19743, May 2, 1996]